1. Field of the Invention
The invention relates to a closure cap for a container for receiving medical liquids, and in particular an infusion or transfusion container, which closure cap has a cover portion and a rim portion. As well as this, the invention also relates to a container for receiving medical liquids, and in particular a BFS container, which has a closure cap of this kind.
2. Background Art
There is a process, known as the blow-fill-seal process (BFS process), in which, in a single operation and sterilely and while remaining pyrogen-free, containers, such for example as bottles of extruded PE or PP, are blown to a desired shape and immediately on cooling are filled aseptically with a desired filling and are hermetically sealed. The containers, and in particular the bottles, which are produced by the blow-fill-seal process are also referred to as BFS containers.
When known BFS containers are used to receive sterile medical liquids, such for example as infusion solutions, they require a closure cap system which allows the infusion solution to be transferred to the patient by means of an infusion device. It should also be possible for medications to be added to the infusion solution.
Known from WO 96/23545 is an infusion bag which has an injection part and a withdrawal part. The withdrawal part is used to allow the infusion solution to be withdrawn by means of a spike, whereas the injection part is used to allow a medication to be fed in by means of an injection syringe which has a thin needle. The injection part comprises a tubular portion for connection which is closed off by a protective cap in the form of a break-off part. Seated in the portion for connection is a self-sealing membrane (septum) which is pierced by the needle of the injection syringe. A piercable membrane in the portion for connection stops the septum from coming into contact with the solution before the infusion bag is used. The withdrawal part does not have a self-sealing septum. The injection and withdrawal parts known from WO 96/23545 are intended to be welded into an infusion bag.
The known injection parts have proved satisfactory in practice. There are however disadvantages which arise from the use of an injection needle for injecting an active agent. On the one hand there is a risk of the connection between the injection needle and the septum becoming disconnected due to an unintentional pull on the syringe or a pressure above atmospheric inside the bag. On the other hand there is an increased risk of injury to the nursing staff due to the injection needle. The infusion bag into which the injection part is welded may also be damaged by the needle in the event of inexpert handling. As well as this, it is also more difficult for a viscous active agent to be fed in due to the small cross-section of the needle. In addition, it takes a relatively long time even to feed in an active agent of low viscosity due to the small cross-section of the needle.
For connecting up medical devices, there are in medical engineering known conical connectors with a conical tip and a conical socket whose conical surfaces are standardised. The non-lockable conical connectors having standardised conical surfaces are referred to as Luer connectors and the lockable conical connectors are referred to as Luer-lock connectors. Luer or Luer-lock connectors having a conical tip are referred to as male connectors and the connectors having conical sockets are referred to as female connectors.
DE 103 48 016 A1 describes a connector for welding into an infusion bag which allows an active agent to be injected by means of a conventional Luer-lock syringe which does not have an injection needle. The known connector has a portion for connection which has a recess in the form of a passage in which a self-sealing membrane is arranged. A break-off part which is connected to the portion for connection seals off the recess in passage form. Above the membrane, the portion for connection takes the form of a connecting piece having an internal cone and an outside thread, the membrane being slit to receive the conical tip of a syringe while forming a seal against it. The connector is made up of an upper sub-section and a lower sub-section between which the self-sealing membrane is held by a clamping action.
Known from DE 20 2004 003 267 U1 is a closure cap for a BFS container which has a cover portion and an rim portion, a slit membrane which allows the spike of an infusion device to be inserted being inserted in the cover portion. The slit membrane is seated in the cover portion of the closure cap flush therewith.
The object underlying the invention is to provide a closure cap for a container for receiving medical liquids, and in particular a BFS container, which closure cap allows a liquid to be injected without the use of an injection needle. As well as this, it is also an object of the invention to provide a container for receiving medical liquids, and in particular a BFS container, which makes it possible for a liquid to be injected without the use of an injection needle.
These objects are achieved in accordance with the invention by virtue of the features specified in the claims. Preferred embodiments of the invention form the subject matter of the dependent claims.
The closure cap according to the invention for a container for receiving medical liquids, and in particular a BFS container for receiving an infusion solution, has a cover portion and a rim portion, an injection part for the injection of a medical liquid being arranged in the cover portion.
The injection part has an outward-pointing portion for connection having a conical recess to receive the conical tip of a needleless injection syringe while forming a seal against it, and an inward-pointing closing-off portion which has a self-sealing membrane to close off the recess in the portion for connection. The self-sealing membrane is slit and the conical tip of the injection syringe can thus be inserted easily.
It is of advantage for the closure cap according to the invention to be formed in one piece except for the self-sealing membrane. This makes it possible for the closure cap to be manufactured in large numbers at low cost.
In a preferred embodiment of the closure cap, the closing-off portion of the injection part has a recess in which the self-sealing membrane is inserted by being snapped into place. The self-sealing membrane is preferably fixed in place in the recess by an inwardly projecting rim of the closing-off portion by a clamping action. Rather than an inwardly projecting rim which extends around the entire circumference of the closing-off portion, the closing-off portion may also have hooks arranged to be distributed around the circumference to fix the self-sealing membrane in position by a clamping action.
In a further preferred embodiment of the invention, the recess in the closing-off portion has a first cylindrical section which merges with the cover portion, and a second cylindrical section which follows on from the first cylindrical section, the first cylindrical section being of a smaller inside diameter than the second cylindrical section.
A preferred embodiment of the closure cap makes provision for the self-sealing membrane to have an annular section which is arranged in the second cylindrical section of larger inside diameter of the recess, and a dished section which follows on from the annular section by way of a central web and which is arranged in the first cylindrical section of smaller inside diameter. The self-sealing membrane thus has a secure hold in the recess in the closing-off portion.
The dished section of the self-sealing membrane preferably has a bowl-like depression. The bowl-like depression on the one hand ensures that that the conical tip of the syringe is reliably guided and on the other hand guarantees that the membrane seals reliably on the conical tip being withdrawn. It has been found in tests that the special configuration of the membrane is crucial to immediate re-closure, the sealing of the membrane being further increased as the internal pressure in the pack increases.
In an embodiment which is a particular preference, the closing-off portion of the injection part having the self-sealing membrane is so designed that, when the conical tip of the injection syringe is inserted, the membrane is compressed in the axial direction in the recess. As a result, the membrane opens when the conical tip is inserted. On the one hand the self-sealing membrane is adequately fixed in place in the recess in the closing-off portion but on the other hand is so freely movable that the membrane can be compressed in the axial direction when the conical tip is inserted. The height of the membrane is reduced when this happens, i.e. the top face of the membrane loses contact with the surface of the closing-off portion against which it rests.
The closing-off portion of the injection part may be designed for a Luer syringe or a Luer-lock syringe. The portion for connection of the injection part preferably has an outside thread, thus enabling a Luer-lock connection to be made to the syringe.
To allow the self-sealing membrane to be closed aseptically, the portion for connection is preferably sealed off by a break-off part which is connected to the top end of the portion for connection via an annular zone for fracture. On the break-off part being broken off, the self-sealing membrane is exposed and the conical tip of the syringe can thus be inserted.
To improve handling, the break-off part preferably has a lateral tab for gripping which extends to the rim portion of the cover portion of the closure cap.
As well as the injection part, the closure cap according to the invention may also have a withdrawal part to allow a medical liquid to be withdrawn with a spike. The withdrawal part preferably also has an outward-pointing portion for connection having a recess into which a spike is inserted, and an inward-pointing closing-off portion which is closed off by a self-sealing membrane.
The piercable membrane is inserted in a recess in the closing-off portion of the withdrawal part by being snapped into place. The membrane is preferably fixed in place by an inwardly projecting rim of the closing-off portion by a clamping action. The closing-off portion of the withdrawal part too is preferably closed off by a break-off part which is connected to the top end of the portion for connection via an annular zone for fracture. The break-off part of the withdrawal part too preferably has a lateral tab for gripping which extends to the rim portion of the cover portion.
The container according to the invention, which is in particular an infusion or transfusion container which preferably takes the form of a bottle, is closed off by the closure cap described above.
An embodiment of the invention will be described in what follows by reference to the drawings.
FIGS. 1 and 2 are side elevations of the closure cap according to the invention which has an injection part A and a withdrawal part B. Except for the self-sealing, or in other words piercable, membrane, the closure cap is a one-piece component made of plastics material which can be inexpensively manufactured in large numbers.